FDA.reportPublic FDA data

SurgiMac

Primary DI
TDS61163000
Brand
SurgiMac
Company
Surgimac LLC
Model
T6116-S-CS
Device description
Blue Nitrile 300/BX, 10/CS. Small. MacSoft. Thailand.
Published
2024-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
TDS61163000PrimaryHIBCC0
TD1056116SCS3000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Regulatory Flags#

DUNS number
060635048
Device count
3000
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D105VP9008MI4MacImpressVP-9008-MIVP9008MI2026-07-06
D1051013021MacSafe10-13021013022026-06-26
D1051013031MacSafe10-13031013032026-06-26
D1051013041MacSafe10-13041013042026-06-26
D1051013011MacSafe10-13011013012026-06-25
D105VP9008MI10MacImpress VP-9008-MI-12025-11-07
D105VP9007MI2MacImpress VP-9007-MI2025-09-25
D105VP9011MI2MacImpress VP-9011-MI2025-09-25
D105VP9007MI11MacImpress VP-9007-MI-12025-09-25
D105VP9007MI21MacImpress VP-9007-MI2025-09-25
D105VP9011MI11MacImpress VP-9011-MI-12025-09-25
D105VP9011MI21MacImpress VP-9011-MI2025-09-25
D105121781MacBite121782025-08-15
D1051217840MacBite12178-42025-08-15
D105121789MacBite121782025-08-15
D1051217849MacBite12178-42025-08-15
D1057115XS0MacTouch 7115-XS2025-08-14
D1057115XSCS1MacTouch 7115-XS-CS2025-08-14
D1057116S0MacTouch 7116-S2025-08-14
D1057116SCS1MacTouch 7116-S-CS2025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
00199536900219BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900219BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900219BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03